Bioelectrical Response to Standardized Preoperative Hydration and Its Association With Short- and Long-Term Outcomes After Elective Colon and Rectal Resections: An Ambispective Controlled Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Participants With at Least One Clavien-Dindo Grade II-V Postoperative Complication
研究概览
简要总结
This single-center study will evaluate whether short-term changes in bioelectrical impedance measurements after a standardized preoperative intravenous fluid infusion can help predict complications following elective colon or rectal surgery. The prospective group will include 120 consecutive adults. After emptying the bladder, participants will be weighed and assessed barefoot on a standing multifrequency bioelectrical impedance device. They will then receive Ionolyte, a balanced isotonic crystalloid, at 15 mL/kg based on the lower of actual and ideal body weight, up to 1,000 mL, over exactly 40 minutes. Participants will empty the bladder again and undergo repeat measurement 60 minutes after infusion start. The main predictor is the continuous change in phase angle, and the main outcome is at least one Clavien-Dindo grade II-V complication within 30 days. A supportive analysis will compare clinical outcomes with 240 consecutive historical controls using existing hospital records. The historical controls do not receive the study procedure and are not included in the prospective enrollment.
详细描述
The prospective component is protocol-assigned, non-randomized, open-label, and single-group. Dosing weight is the lower of actual body weight measured at T0 and ideal body weight calculated from sex and height using the Robinson equations. An eGFR of at least 60 mL/min/1.73 m² is an eligibility criterion and is not used to calculate fluid volume.
From infusion start through T60, food, drink, and other intravenous fluids are withheld unless clinically required. Routine walking to the toilet and standing scale is permitted. Only T0 and T60 research BIA measurements are performed. Clinical care takes priority over the protocol, and symptoms or clinician concern require stopping the infusion and performing a medical assessment.
Short-term outcomes are assessed through 90 postoperative days. Long-term outcomes include overall survival and, in participants with malignant disease, recurrence-free survival for up to five years.
The complete ambispective research program also includes 240 consecutive eligible patients operated on immediately before implementation of the prospective protocol. Their data are obtained retrospectively from existing University Hospital of Split records without contact or additional procedures, under the approved waiver of consent. This historical comparison is not a prospectively assigned ClinicalTrials.gov arm and is not included in the anticipated enrollment of 120.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Scheduled for elective colon or rectal resection at University Hospital of Split
- •Written informed consent before research-specific procedures
- •Able to stand safely and complete both BIA measurements
- •Preoperative eGFR at least 60 mL/min/1.73 m²
- •Clinically eligible for the protocol fluid volume
排除标准
- •Emergency surgery
- •eGFR below 60 mL/min/1.73 m² or oliguria
- •Heart failure or clinically significant cardiac disease making fluid loading inappropriate
- •Edema, pulmonary congestion, or clinically significant ascites
- •Active implantable electrical device
- •Limb amputation, inability to undergo standardized standing BIA, or unsafe standing
- •Clinically significant electrolyte abnormality
- •Pregnancy
- •Contraindication to Ionolyte or any clinician safety concern
- •Inability to provide valid informed consent
研究组 & 干预措施
Standardized Ionolyte Hydration and Serial BIA
Prospective participants undergo standardized BIA and weighing at T0 after bladder emptying, protocol-defined Ionolyte infusion over exactly 40 minutes, repeat bladder emptying, and BIA and weighing at T60, followed by usual elective colon or rectal resection and outcome follow-up.
干预措施: Ionolyte Balanced Isotonic Crystalloid (Drug)
结局指标
主要结局
Participants With at Least One Clavien-Dindo Grade II-V Postoperative Complication
时间窗: From surgery through postoperative day 30
Number and proportion of participants experiencing at least one postoperative complication graded II, III, IV, or V according to the Clavien-Dindo classification.
次要结局
- Change in Phase Angle(T0 to 60 minutes after infusion start)
- Change in Extracellular Water(T0 to 60 minutes after infusion start)
- Major Postoperative Complications(Through postoperative day 30)
- Comprehensive Complication Index(Through postoperative day 30)
- Surgical-Site Infection(Through postoperative day 30)
- Anastomotic Leakage(Through postoperative day 30)
- Number of Participants With Acute Kidney Injury(From surgery through postoperative day 30)
- Length of Hospital Stay(From colon or rectal resection through discharge from the hospitalization during which the resection was performed, up to 90 days after surgery)
- Number of Participants With an Unplanned Reoperation(Through postoperative day 30)
- Number of Participants With Hospital Readmission(Through postoperative day 30)
- All-Cause Mortality(Postoperative days 30 and 90)
- Overall Survival(Up to 5 years after surgery)
- Recurrence-Free Survival(Up to 5 years after surgery)
- Change in Intracellular Water(T0 to 60 minutes after infusion start)
- Change in Total Body Water(T0 to 60 minutes after infusion start)
- Change in Extracellular Water to Total Body Water Ratio(T0 to 60 minutes after infusion start)
- Change in Whole-Body Resistance at 50 kHz(T0 to 60 minutes after infusion start)
- Change in Whole-Body Reactance at 50 kHz(T0 to 60 minutes after infusion start)
- Change in Body Weight(T0 to 60 minutes after infusion start)
研究者
Ognjen Barčot, MD, PhD
Assistant Professor
University Hospital of Split